BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 1

    MDR report key: 8331034 · Received February 12, 2019

    Report

    Report Number
    3005180920-2019-00048
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 12, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804663
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 FEBRUARY 2019: LOT 152565: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: MECTACER REFERENCE 01.29.203 (K112115) BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5 LOT 161742: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2016. EXPIRATION DATE: 2021-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 2 OTHER SIMILAR REPORTED EVENTS. VERSAFITCUP DM REFERENCE 01.26.2852MHC (K092265) DOUBLE MOBILITY HC LINER Ø 52/28. LOT 157671: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2016. EXPIRATION DATE: 2021-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VERSAFITCUP 01.26.52MB (K083116) ACETABULAR SHELL Ø 52. LOT 160204: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2016. EXPIRATION DATE: 2021-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL THE PATIENT HARDWARE FOR INFECTION. ANTIBIOTIC SPACER INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124808 AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 152565 07630030804663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention